Regulatory Affairs

Our regulatory team has everything you need to achieve successful agency dialogue, plan your regulatory strategy, achieve timely submissions and approvals. Whatever your regulatory need, we're here to help.

Understanding ever-changing regulatory demands and embracing new regulatory initiatives are essential for optimal drug development. Our regulatory experts provide our clients with effective support through intimate knowledge of global and local regulations.

At tranScrip, we approach every new project holistically. Our regulatory team specialises in regulatory affairs, quality systems and compliance for products including New Chemical Entities (NCEs), known drug substances, medical devices, in-vitro diagnostics and drug device combinations. We are equally comfortable working on drug substances which originate as small molecule or large molecule biologics, including advanced therapy products, incorporating specialist delivery platforms or devices and companion diagnostics.

The team comprises dedicated experienced experts to support and advise our clients on meeting their regulatory obligations. From exploring ways to maximise your outputs from dialogue with the stakeholder agencies, to helping ease your product’s journey through assessment, our specialists are on your side.

The regulatory affairs consulting team has everything you need to achieve successful regulatory submissions and approvals. Whether it's a first-in-man study, a new product application, a renewal, or label extension; we are here to help.

We also offer you peace of mind. Part of our daily activities include horizon scanning, and as a result we are very well versed on the latest guidance.

We know the regulatory landscape inside out. It is what we do. We see our role as one of risk reduction, irrespective of the stage of the product life cycle.

Each stage has its own specific needs.

How can we support you?

We operate over the whole of the life cycle, with a bespoke experienced team having a variety of backgrounds and the necessary skill sets to support with:

  • Regulatory strategy and maximising opportunities for agency dialogue during development
  • Oversight of clinical trials or clinical investigations
  • Technical input and authoring of specialist regulatory documentation for medicines, medical devices and combination products
  • Incorporating device or drug delivery platforms and companion diagnostics
  • Managing regulatory submission processes
  • Maintaining regulatory compliance and quality systems
  • Support with agency audits

We are just waiting for the opportunity to show you what we can do.

tranScrip Overview

09 May 23

Contact our team of experts

Our physicians, scientists and service experts can help to maximise the value of your products. Whatever your project requires, we have the people to meet your needs.